BonOs Inject
- Primary DI
- 04260056883231
- Brand
- BonOs Inject
- Company
- OSARTIS GmbH
- Model
- 01-0309
- Device description
- BonOs® Inject is a radiopaque, injectable bone cement for the treatment of pathological fractures of the vertebral body due to osteoporosis, cancer, or benign lesions using vertebroplasty or balloon kyphoplasty procedure. When used in conjunction with NEO Pedicle Screw System™ BonOs® Inject is intended to restore the integrity of the spinal column even in the absence of fusion for a limited time in patients with advanced stage tumors involving the thoracic and lumbar spine in whom life expectancy is of insufficient duration to permit achievement of fusion. NEO Pedicle Screws augmented with BonOs® Inject Cement are for use at spinal levels where the structural integrity of the spine is not severely compromised.Mixing the two separate sterile components initially produces a ductile, injectable bone cement which, after hardening in situ, is able to stabilize neoplastic vertebral lesions and vertebral compression fractures. BonOs® Inject cement powder also contains insoluble zirconium dioxide as an X-ray contrast medium.
- Published
- 2015-10-02
- Public version status
- Update
- Distribution status
- In Commercial Distribution
- MRI safety
- Labeling does not contain MRI Safety Information
- Rx
- true
- Sterile
- true
- Single use
- true
Product Codes#
Product Code Classifications#
Identifiers And Packaging#
| Identifier | Type | Agency | Package quantity | Status |
|---|---|---|---|---|
| 14260056883238 | Package | GS1 | 20 | In Commercial Distribution |
| 04260056883231 | Primary | GS1 | 0 |
Alternate GTIN / UPC / EAN Codes
| Source identifier | GTIN-14 normalized | EAN-13 |
|---|---|---|
| 14260056883238 | 14260056883238 | |
| 04260056883231 | 04260056883231 | 4260056883231 |
GMDN Terms#
| Term | Definition |
|---|---|
| Vertebral bone filler, non-bioabsorbable | A sterile substance intended to be used to replace cortical/cancellous bone in a vertebral body to stabilize vertebral compression fractures (VCFs) caused by cancer, osteoporosis, or trauma. The device may be a sterile powder of a synthetic polymer [e.g., polymethylmethacrylate (PMMA)] that is mixed with its sterile diluent, or a non-PMMA-containing elastomer formed by mixing two precursors, prior to implantation typically during a balloon kyphoplasty or vertebroplasty procedure. This device does not contain an antibiotic agent. After application, this device cannot be reused. |
Device Sizes#
| Type | Value | Unit |
|---|---|---|
| Weight | 24 | Gram |
Storage And Handling#
| Type | Low | High | Condition |
|---|---|---|---|
| Handling Environment Temperature | 18 Degrees Celsius | 25 Degrees Celsius | |
| Special Storage Condition, Specify | 0 | 0 | Store between 0°C (32°F) and 25°C (77°F) |
Sterilization Methods#
| Method |
|---|
Regulatory Flags#
- DUNS number
- 344261631
- Device count
- 1
- Lot or batch
- true
- Expiration date on label
- true
Other Devices From This Company#
| Primary DI | Brand | Model | Catalog | Published |
|---|---|---|---|---|
| 04260056880674 | XPERIENCE Advanced Surgical Irrigation | SL-0005 | MC-SL-0005-10 | 2026-04-01 |
| 04260056880643 | BLASTX® | WG-0001 | MC-WG.0001-12 | 2026-02-19 |
| 14260056880640 | BLASTX® | WG-0001 | MC-WG.0001-12 | 2026-02-19 |
| 04260056882579 | BonOs HV | 1x40 | 01-0162 | 2024-05-17 |
| 04260056882623 | BonOs HV Genta | 1x40 | 01-0262 | 2024-04-03 |
| 04260056880759 | Vertecem II Cement Kit | 08.702.017S | 08.702.017S | 2015-10-21 |
| 04260056880612 | EASYMIX® Nozzle slim | 02-0104 | 02-0104 | 2022-12-01 |
| 04260056880919 | EASYMIX® Nozzle revision | 02-0105 | 02-0105 | 2022-12-01 |
| 14260056880619 | EASYMIX® Nozzle slim | 02-0104 | 02-0104 | 2022-12-01 |
| 14260056880916 | EASYMIX® Nozzle revision | 02-0105 | 02-0105 | 2022-12-01 |
| 04260056881022 | EASYMIX® compressed air hose | 02-0205 | 02-0205 | 2022-12-01 |
| 04260056881039 | EASYMIX® compressed air hose | 02-0206 | 02-0206 | 2022-12-01 |
| 04260056881633 | EASYMIX® vacuum pump I | 02-0401 | 02-0401 | 2022-12-01 |
| 04260056881930 | EASYMIX® vacuum pump II | 02-0201 | 02-0201 | 2022-12-01 |
| 04260056881251 | EASYMIX cement injector | 02-0504-04 | 02-0504-04 | 2022-11-28 |
| 04260056884412 | EASYMIX pro | 02-0305 | 02-0305 | 2021-11-11 |
| 04260056884429 | EASYMIX pro | 02-0305 | 02-0305 | 2021-11-11 |
| 04260056881565 | ManuMix | 02-0601 | 02-0602 | 2021-10-12 |
| 04260056881572 | ManuMix | 02-0601 | 02-0602 | 2021-10-12 |
| 04260056885624 | BonOs R 1x40 | 01-0117 | 2015-09-25 |
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| 07613327545258 | AutoPlex VertaPlex | STRYKER CORPORATION | NDN | 2024-11-21 |
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| 07613327638240 | Omnicurve | STRYKER CORPORATION | NDN | 2024-09-03 |
| 07613327638257 | Omnicurve | STRYKER CORPORATION | NDN | 2024-09-03 |
| 07613327638431 | Omnicurve | STRYKER CORPORATION | NDN | 2024-09-03 |
| 07613327554724 | Omnicurve | STRYKER CORPORATION | NDN | 2023-11-07 |
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